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EC number: 457-310-8 | CAS number: -
The repeated dose toxicity of tetraammineplatinum(II) diacetate was assessed in a 28-day oral study conducted according to GLP and OECD Test Guideline 407.
Wistar rats (5/sex/group) were given a daily gavage administration of tetraammineplatinum diacetate at 0 (given water), 50, 150 or 1000 mg/kg bw/day for 28 days. Throughout the study, animals were observed daily for mortality and other overt clinical signs of toxicity. Body weight and food and water consumption were monitored. At the end of the study, blood samples were collected from each surviving rat for the analysis of haematological parameters and clinical chemistry. This was immediately followed by sacrifice and scheduled necropsy, in which a comprehensive range of organs and tissues were examined macroscopically and microscopically.
Due to poor clinical condition, all rats given 1000 mg/kg bw/day were sacrificed on day six. The haematological parameters and clinical chemistry of these animals were not examined. In this high dose group, animals showed a marked reduction in weight (up to 25%) and severely reduced food consumption relative to control animals. Post mortem examination showed significant organ weight reductions and adverse effects on the gastro-intestinal tract (an overfilled stomach, discolouration, thickening of the colon) and caecum (discolouration, thickening). Cellular effects, possibly indicative of organ toxicity, were observed in the spleen, sternal bone marrow and thymus.
No toxicologically significant adverse effects were observed in rats given 50 or 150 mg/kg bw/day by gavage for 28 days. Therefore, the no-observed-adverse-effect level (NOAEL) was considered to be 150 mg/kg bw/day.
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